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Child clinical trials

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NCT ID: NCT02634099 Completed - Child Clinical Trials

A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery

Hemoped
Start date: January 5, 2016
Phase: N/A
Study type: Interventional

Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

NCT ID: NCT02616419 Completed - Child Clinical Trials

External Cold and Vibration Stimulation (Buzzy®) for Procedural Pain Management in Children Undergoing Needle-Related Procedures

Start date: May 15, 2017
Phase: N/A
Study type: Interventional

Since the late 1980s, several studies focused on pediatric procedural pain and show that it still underevaluated and undertreated, especially in the Emergency Department (ED). Needle-related procedures are the most important source of pain and anxiety and children. Since it is impossible to completely eliminate the pain and anxiety experienced by children during painful procedures, use of non-pharmacological and/or pharmacological interventions might be beneficial. Most methods used for relief of procedural pain and anxiety for children require time or extra staff, which represent barriers to their implantation in the ED. An easy-to-use and rapid non-pharmacological intervention could overcome these constraints and optimize procedural pain and anxiety relief in children undergoing a needle-related procedure. The primary objective of this study is to determine if a device combining cold and vibration (Buzzy®) is non-inferior (no worse) than a topical anesthetic cream (lidocaine liposomal 4%) for procedural pain management in children undergoing needle-related procedures in the ED. Investigators strongly believe that the use of the Buzzy® device in the ED will improve significantly the pain and anxiety felt by children undergoing needle-related procedures. Since EDs are usually chaotic and very busy, an easy-to-use and rapid non-pharmacological intervention like the Buzzy®, will surely be adopted by the nursing personnel as a useful tool for procedural pain. Given this knowledge, the investigators feel that this randomized controlled trial will have the potential to improve nursing practice and optimize painful experiences of children undergoing needle-related procedures.

NCT ID: NCT02551978 Completed - Obesity Clinical Trials

Kids Obesity Prevention Program - Study (KOP)

KOP
Start date: September 2015
Phase: N/A
Study type: Interventional

Obesity and its associated comorbidities are becoming a key and rapidly growing public health problem. The cause of obesity is an imbalance between energy intake and energy expenditure in favor of the former. Childhood and adolescence are seen as critical time for its development. It is therefore crucial to provide both prevention and treatment actions already during childhood. The prevention and treatment weight-management programs in children focus on improving diet, eating behaviours, psychosocial aspects and increasing physical activity. One important basic requirement for any weight-management program is, that both children and their families are motivated and ready for change. Video games, including exergames, serious games or combined approaches offer additional chances in the treatment and prevention of obesity by approaching children in their environment and motivating them to deal with life-style topics. The investigators developed a motion-controlled serious game for children aged between 9 and 12 years, addressing all the three core areas nutrition, physical activity, and psychosocial factors. In addition to the motion control, a tablet is used for knowledge-based and cognitive tasks. In comparison to other studies the nutrition part not only deals with the food pyramid but also with the energy density of foods and liquids and offers a self-reflexive diagnostic tool to analyse daily food intake. Moreover, psychological aspects, especially stress and stress-coping strategies are addressed e.g. by relaxation-exercises. The game consists of two sessions, having each a duration of about 35 minutes. The aim of this study is to evaluate the program in a cluster-randomized controlled trial in a primary school setting in children aged 9 to 12 years. Therefore, six 4th grade classes of the same school will be randomly allocated to an intervention and a control group. The intervention group will play the game within two weeks, whereas the control group will receive basic information. At baseline, two weeks after baseline and at four weeks follow-up, measurements will be performed. The primary outcome of the study is the gain of knowledge (nutrition, psychosocial aspects) measured by a self-constructed questionnaires tailored specifically for the serious game. Secondary outcomes are the acceptance of the game, changes of nutrition behaviour, physical activity and intentions of the children to follow a healthy lifestyle, measured by mostly validated questionnaires.

NCT ID: NCT02503579 Completed - Child Clinical Trials

The Role of Brain-derived Neurotropic Factor in the Relationship Between Executive Function and Physical Training

Start date: August 2015
Phase: N/A
Study type: Interventional

This doctoral thesis has the aim to identify the role of Brain-derived neurotropic factor in the relationship between physical fitness/activity and executive functions in typically developing children and children with Autism Spectrum Disorder, Development Coordination Disorder , Attention Hyperactive Disorder.

NCT ID: NCT02485314 Completed - Child Clinical Trials

Reliability and Validity of Turkish Version of PEM-CY

Start date: March 2016
Phase:
Study type: Observational

The Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings. The aim of this study was to examine reliability and validity of Turkish version of the Participation and Environment Measure for Children and Youth (PEM-CY).

NCT ID: NCT02471521 Completed - Anesthesia Clinical Trials

Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas. For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

NCT ID: NCT02464865 Completed - Obesity Clinical Trials

Thiamin Deficiency in Obese Thai Children

Start date: August 2015
Phase: Phase 4
Study type: Interventional

This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

NCT ID: NCT02463149 Completed - Child Clinical Trials

Pilot Evaluation of Youth Chef Academy

YCA
Start date: August 2011
Phase: N/A
Study type: Interventional

This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based experiential culinary and nutrition literacy curriculum for middle-school students. The primary study hypothesis was that students assigned to YCA would demonstrate greater improvement in F/V and whole grain consumption compared to students in the control group. Eight classrooms in eight public K-8 schools participated in the project. Classrooms were assigned to intervention or control condition in a non-randomized manner. YCA was delivered by project staff to all of the students in the four intervention classrooms. Students completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum cohort).

NCT ID: NCT02378311 Completed - Trauma Clinical Trials

Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury?

GRIP
Start date: March 2015
Phase: N/A
Study type: Observational

Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5]. One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube. This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition. Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls]. If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing. Data collection for this feasibility study will occur between March 2015 and September 2015. The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.

NCT ID: NCT02348073 Completed - Epilepsy Clinical Trials

Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy

AGPIn3
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Our project aims to develop a new therapeutic approach in epilepsy-associated attention disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids, containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children with epilepsy. Secondary objectives include: - To evaluate the impact of a supplementation of PS-Omega 3 on quality of life. - To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid profiles. - To assess the tolerance of a supplementation of PS-Omega 3. - To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures. - To describe the impact of a supplementation of PS-Omega 3, at 24 weeks, 1. on attention disorders in children with epilepsy, 2. on quality of life, 3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects aged 6- 16 years, suffering from epilepsy (any type) and attention deficit hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V criteria in 12 clinical sites in France.